Identifying Patients With Suspicion of Infection in the ED Who Have Low Disease Severity Using MR-proADM - Pilot Study

Patients Presenting With Suspicion of Infection to the ED Clinical Trial

— IDEAL  

Official title:

Identifying Patients With Suspicion of Infection in the ED Who Have Low Disease Severity Using Midregional Proadrenomedullin (MR-proADM) - Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03770533
• Other study ID #: IDEAL pilot
• Status: Completed
• Phase: N/A
• Start date: December 14, 2018
• Est. completion date: December 11, 2019

Study information

• Verified date: December 2019
• Source: Brahms AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Emergency departments (ED) are becoming increasingly over-crowded, with patients facing prolonged waiting times. Therefore, a safe and rapid assessment that identifies patients with low severity that could be treated as outpatients is essential for improving the workflow within the ED.

The rationale of this IDEAL study is to provide guidance to safely decrease the number of hospital admissions through identification of low risk patients with the biomarker MR-proADM. This will be tested in a pilot study first.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 11, 2019
• Est. primary completion date: December 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Consecutive patients presenting to the ED with suspicion of infection

• Age =18 years

• Written Informed Consent obtained

Exclusion Criteria:

• Recent major trauma or surgery

• End stage renal failure requiring dialysis

• Terminal disease and/or very severe medical co-morbidity where death has to be expected in the next 6 months, e.g. due to malignancy, cardiac, renal or hepatic failure

• Patients those source of infection always requires hospital admission or never requires hospital admission.

• Patients who cannot be discharged for other than medical reasons

• Patient participates in any other interventional clinical trial

• Patients with active intravenous drug use

• Pregnant or lactating women

• Patients who are institutionalized by official or judicial order

• Dependents of the sponsor, the CRO, the study site or the investigator

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Patients Presenting With Suspicion of Infection to the ED

Intervention

Other:
• MR-proADM guided
MR-proADM value together with routine clinical evaluation identifies patients with a low 14 day mortality risk who do not need to be hospitalized

Locations

Country	Name	City	State
Spain	Hospital Universitario de Bellvitge	Barcelona
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias
Spain	Hospital Virgen Macarena	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Brahms AG

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients admitted to the hospital		14 days
Secondary	28 days all-cause hospital re-admission (corrected for mortality)		28 days
Secondary	Number of patients re-presenting to the ED within 28 days		28 days